Clinical Data Management Toolkit

Save time, empower your teams and effectively upgrade your processes with access to this practical Clinical Data Management Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any Clinical Data Management related project.

Download the Toolkit and in Three Steps you will be guided from idea to implementation results.

The Toolkit contains the following practical and powerful enablers with new and updated Clinical Data Management specific requirements:

STEP 1: Get your bearings

Start with...


• The latest quick edition of the Clinical Data Management Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.


Organized in a data driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the…


• Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation


Then find your goals...

STEP 2: Set concrete goals, tasks, dates and numbers you can track

Featuring 991 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Clinical Data Management improvements can be made.

Examples; 10 of the 991 standard requirements:


1. Is the concept of big data going to live up to the increasing hype of its promise to transform knowledge discovery, population health management, clinical decision support, and predictive analytics?
   
   

2. Are mechanisms in place to capture the necessary data to inform quality service provision, competent case management and feed into the overall cycle of commissioning?
   
   

3. How important is it that your organization/drug development industry embrace the utilization of big data practices in clinical trials?
   
   

4. How do you know what options are best for your team and what options will help organizational efficiency and improve clinical quality?
   
   

5. How is identification of risks and benefits implemented within GCP and where may information about risks and benefits be obtained?
   
   

6. Is there a way to know how each shift/unit/department is doing in a clinical area, or is there only facility level data available?
   
   

7. What types of information capabilities do you need to build in order to identify populations for population health management?
   
   

8. Are you in clinical data management using data analytics as effectively as your peers in marketing or commercial operations?
   
   

9. Do your clinical application systems facilitate automated monitoring and measurement of data retention compliance?
   
   

10. Are the research screening procedures similar to the procedures being used for clinical appointments/procedures?
    
    


Complete the self assessment, on your own or with a team in a workshop setting. Use the workbook together with the self assessment requirements spreadsheet:


• The workbook is the latest in-depth complete edition of the Clinical Data Management book in PDF containing 991 requirements, which criteria correspond to the criteria in...


Your Clinical Data Management self-assessment dashboard which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next:


• The Self-Assessment Excel Dashboard; with the Clinical Data Management Self-Assessment and Scorecard you will develop a clear picture of which Clinical Data Management areas need attention, which requirements you should focus on and who will be responsible for them:
  
  


• Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix

• Gives you a professional Dashboard to guide and perform a thorough Clinical Data Management Self-Assessment

• Is secure: Ensures offline data protection of your Self-Assessment results

• Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next:



STEP 3: Implement, Track, follow up and revise strategy

The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage Clinical Data Management projects with the 62 implementation resources:


• 62 step-by-step Clinical Data Management Project Management Form Templates covering over 1500 Clinical Data Management project requirements and success criteria:


Examples; 10 of the check box criteria:


1. Lessons Learned: How useful was the format and content of the Clinical Data Management project Status Report to you?
   
   

2. Procurement Management Plan: Were Clinical Data Management project team members involved in the development of activity & task decomposition?
   
   

3. Schedule Management Plan: Is your organization certified as a broker of the products/supplies?
   
   

4. Risk Audit: What is happening in other jurisdictions? Could that happen here?
   
   

5. Risk Audit: Do you have position descriptions for all office bearers/staff?
   
   

6. Planning Process Group: What is the critical path for this Clinical Data Management project, and what is the duration of the critical path?
   
   

7. Team Directory: Process decisions: which organizational elements and which individuals will be assigned management functions?
   
   

8. Cost Management Plan: Are enough systems & user personnel assigned to the Clinical Data Management project?
   
   

9. Milestone List: Do you foresee any technical risks or developmental challenges?
   
   

10. Activity Duration Estimates: Is a formal written notice that the contract is complete provided to the seller?


 
Step-by-step and complete Clinical Data Management Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:


• 1.1 Clinical Data Management project Charter

• 1.2 Stakeholder Register

• 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:


• 2.1 Clinical Data Management project Management Plan

• 2.2 Scope Management Plan

• 2.3 Requirements Management Plan

• 2.4 Requirements Documentation

• 2.5 Requirements Traceability Matrix

• 2.6 Clinical Data Management project Scope Statement

• 2.7 Assumption and Constraint Log

• 2.8 Work Breakdown Structure

• 2.9 WBS Dictionary

• 2.10 Schedule Management Plan

• 2.11 Activity List

• 2.12 Activity Attributes

• 2.13 Milestone List

• 2.14 Network Diagram

• 2.15 Activity Resource Requirements

• 2.16 Resource Breakdown Structure

• 2.17 Activity Duration Estimates

• 2.18 Duration Estimating Worksheet

• 2.19 Clinical Data Management project Schedule

• 2.20 Cost Management Plan

• 2.21 Activity Cost Estimates

• 2.22 Cost Estimating Worksheet

• 2.23 Cost Baseline

• 2.24 Quality Management Plan

• 2.25 Quality Metrics

• 2.26 Process Improvement Plan

• 2.27 Responsibility Assignment Matrix

• 2.28 Roles and Responsibilities

• 2.29 Human Resource Management Plan

• 2.30 Communications Management Plan

• 2.31 Risk Management Plan

• 2.32 Risk Register

• 2.33 Probability and Impact Assessment

• 2.34 Probability and Impact Matrix

• 2.35 Risk Data Sheet

• 2.36 Procurement Management Plan

• 2.37 Source Selection Criteria

• 2.38 Stakeholder Management Plan

• 2.39 Change Management Plan


3.0 Executing Process Group:


• 3.1 Team Member Status Report

• 3.2 Change Request

• 3.3 Change Log

• 3.4 Decision Log

• 3.5 Quality Audit

• 3.6 Team Directory

• 3.7 Team Operating Agreement

• 3.8 Team Performance Assessment

• 3.9 Team Member Performance Assessment

• 3.10 Issue Log


4.0 Monitoring and Controlling Process Group:


• 4.1 Clinical Data Management project Performance Report

• 4.2 Variance Analysis

• 4.3 Earned Value Status

• 4.4 Risk Audit

• 4.5 Contractor Status Report

• 4.6 Formal Acceptance


5.0 Closing Process Group:


• 5.1 Procurement Audit

• 5.2 Contract Close-Out

• 5.3 Clinical Data Management project or Phase Close-Out

• 5.4 Lessons Learned


Results

With this Three Step process you will have all the tools you need for any Clinical Data Management project with this in-depth Clinical Data Management Toolkit.

In using the Toolkit you will be better able to:


• Diagnose Clinical Data Management projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices

• Implement evidence-based best practice strategies aligned with overall goals

• Integrate recent advances in Clinical Data Management and put process design strategies into practice according to best practice guidelines


Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role; In EVERY company, organization and department.

Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'

This Toolkit empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Clinical Data Management investments work better.

This Clinical Data Management All-Inclusive Toolkit enables You to be that person.

Includes lifetime updates

Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.